Download

DoD Clinical Laboratory Improvement Program (DoD-CLIP)






Advertisement
/ 69 []
Download Presentation
Comments
bernad
From:
|  
(4874) |   (0) |   (0)
Views: 255 | Added: 30-01-2012
Rate Presentation: 0 0
Description:
DoD Clinical Laboratory Improvement Program (DoD-CLIP). Presented By: HMC Gerry S. Rapisura, USN, MT(ASCP) Navy Program Manager, DoD-CLIP MSgt Gary Brown, USAF Air Force Program Manager, DoD-CLIP Center for Clinical Laboratory Medicine (CCLM). Topics for Discussion. Overview of CCLM
DoD Clinical Laboratory Improvement Program (DoD-CLIP)

An Image/Link below is provided (as is) to

Download Policy: Content on the Website is provided to you AS IS for your information and personal use only and may not be sold or licensed nor shared on other sites. SlideServe reserves the right to change this policy at anytime. While downloading, If for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.











- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -




Slide 1

DoD Clinical Laboratory Improvement Program (DoD-CLIP)

Presented By:

HMC Gerry S. Rapisura, USN, MT(ASCP)

Navy Program Manager, DoD-CLIP

MSgt Gary Brown, USAF

Air Force Program Manager, DoD-CLIP

Center for Clinical Laboratory Medicine (CCLM)

Slide 2

Topics for Discussion

  • Overview of CCLM

  • CLIP Program and certificates

  • CAP surveys and inspections

  • CAP PT failures

  • Useful websites

  • Contact Information

Slide 3

History

  • Clinical Laboratory Improvement Act of 1967

    • Applied only to laboratories involved in interstate commerce.

    • Had little impact on the laboratory community

  • Adverse publicity regarding PAP smears and physician office laboratory testing (POL)

  • Response of Congress (amends PL 100-578)

    • The Clinical Laboratory Improvement Amendments of 1988

    • Published March 1992

  • Included Federal Facilities (DOD facilities not exempt)

Slide 4

CLIA'88

  • Purpose: To improve the quality of any testing conducted for medical purposes.

  • Broadly applicable: Congress required every testing site examining “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease…” to be regulated.

Slide 5

CLIA'88

  • Revised and superseded CLIA'67

  • The Centers for Medicare &/Medicaid Studies (CMS) provides oversight for the program

  • Incorporated four separate sets of rules for implementation

  • DOD allowed to develop separate plan with certain restrictions

Slide 6

History Clinical Laboratory Improvement Program (DoD-CLIP)

  • Meeting of representatives from the three services to draft original plan from CLIA 88 - Code of Federal Regulations in April 1992

  • DOD Clinical Laboratory Improvement Advisory Committee met in Washington DC from 20-23 July 1992 and developed final draft of CLIP.

  • Coordinated through Service Surgeon Generals on 29 September 92

Slide 7

DOD Program

  • To be called Clinical Laboratory Improvement Program (DoD-CLIP).

    • AFIP PAM 40-24 – DOD-CLIP Program

  • Very much like CLIA with certain exceptions to meet military operational requirements.

  • Office of Clinical Laboratory Affairs (OCLA), Center for Clinical Laboratory Medicine (CCLM) in AFIP staffed by tri-service personnel and provides oversight for the program.

Slide 8

Registration Required for all DoD Clinical Testing Sites

  • Based on complexity of testing

    • Minimally Complex (Waived)

    • Moderate

      • Provider-Performed Microscopy (PPM)

    • High

  • Currently have 1251 certificates issued with 2471 testing sites

Slide 9

Complexity Definitions

  • Minimal Complexity (Waived) tests are those laboratory examinations and procedures that employ accurate but simple methodologies (mostly FDA approved home tests)

  • Moderate Complexity tests are those defined as moderate complexity by the Centers for Medicare & Medicaid Studies (CMS) and published by the Center for Disease Control (CDC)

Slide 10

Complexity Definitions

  • High Complexity tests are those defined as high complexity by CMS and published by CDC (also includes non-FDA approved procedures)

  • Any deviation from the manufacturers instructions automatically classifies a test as high complexity

  • CDC Web site lists all tests by complexity

    (www.fda.gov/cdrh/CLIA/index.html)

Slide 11

Program Requirements

  • Personnel Standards - Defined for each category of testing (director, clinical consultant, technical consultant, general supervisor, and testing personnel)

  • Quality Control (QC) - monitors the actual analytical testing process

  • Quality Assurance (QA) - all phases of the testing process are monitored

  • Procedure Manuals - meeting National Committee for Clinical Laboratory Science (NCCLS) GP2-A3 format

Slide 12

Program Requirements

  • Patient Test Management Process (Pre, Analytical, Post)

  • Proficiency Testing - Mandatory for PPM, moderate and high complexity sites (even for waived sites, test accuracy must be verified at least twice annually)

  • Inspections and Sanctions - testing privileges are suspended or revoked for facilities out of compliance

Slide 13

Type of Laboratory

Minimal Complexity

Moderate Complexity

PPM

High Complexity

Requirements

Registration and good laboratory practice

QC, QA, PT, Limited Personnel, Accreditation

QC, QA, PT, Stringent Personnel, Accreditation

Overview of DoD CLIP Requirements

Slide 14

Accrediting Organizations (Deemed Status)

  • Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

  • College of American Pathologists (CAP)

    • Army, Air Force and Navy has a centralize contract for PT and Accreditation

  • Commission on Office Laboratory Accreditation (COLA)

  • Certain States also have deemed status

  • Etc.

Slide 15

Registration Process

  • Registration: http://www.afip.org/OCLAB/index.html

    • Initial snapshot of facility

    • Type of laboratory (complexity)

    • Director, by name

    • List of personnel and education

    • Test volume and methodology

  • Certificates are valid for two years

  • Discuss in details on later presentation.

Slide 16

Types of Certificates

  • Registration Certificate

  • Certificate for Minimal Complexity Testing

  • Certificate for Provider-Performed Microscopy

  • Certificate of Compliance

  • Certificates of Accreditation

Slide 17

DoD-CLIP LAP/PT Funding

  • OCLA, CCLM centrally contracts for:

    • Accreditation inspection (LAP) costs for CAP accredited laboratories

    • Proficiency testing (surveys) through CAP

    • Means CCLM will pay your LAP and PT

  • Non-CAP LAP and PT are self pay.

  • Nice to know: Not all CAP PT are funded by CCLM. Check with your corresponding service Program Manager for exemption

Slide 18

QUESTIONS

THANK YOU FOR LISTENING AND YOUR TIME

Slide 19

DoD-CLIP, CCLM

  • Established with an MOA between the DoD and DHHS

  • Purpose is to establish standards and policy for implementation of quality clinical laboratory testing within the DoD

Slide 20

DoD - Clinical laboratory Improvement Program(CLIP) What is it?

  • Military equivalent of CLIA 88 (Clinical Laboratory Improvement Amendments of 1988)

  • Sets forth the minimum conditions that all laboratories must meet to be certified to perform testing under the DoD CLIP

  • Laboratories under DoD jurisdiction are subject to the rules of this program

Slide 21

DoD-CLIP - Exceptions

  • During declared or undeclared wars, or period of mobilization

  • Testing for forensic purposes only

  • Research laboratories that test human specimens, but do not report patient results for diagnosis

  • Some laboratories performing drug testing

  • Medical laboratories assigned to field medical units that perform limited human testing

  • Navy Ship’s Laboratories

Slide 22

CLIP - Complexities

Tests are categorized as one of the following:

  • Minimal complexity (Waived)

  • Non-Waived

    • Moderate complexity, including subcategory provider performed microscopy (PPM)

    • High complexity

Slide 23

CLIP – Laboratories performing minimally complex tests

Definition of minimally complex:

  • A test cleared by the FDA for home use

  • employs methodologies that are simple and accurate

  • pose minimal risk of harm to the patient if performed incorrectly

Slide 24

CLIP – Laboratories performing minimally complex tests

  • Laboratory qualifies for a certificate of minimal complexity if it restricts its tests to minimal complexity

  • Sites with minimal complexity certificates are normally your outlying point of care testing sites

  • Examples: Urine HCG, fecal occult blood, urine dipstick, glucose, cholesterol

Slide 25

CLIP – Laboratories performing minimally complex tests

  • Laboratories eligible for a certificate of minimal complexity must:

    • Follow manufacturer’s instructions

    • Analyze and document controls

    • Ensure training and competency is documented

    • Verify accuracy and reliability at least twice a year

Slide 26

CLIP – Laboratories performing minimally complex tests

A laboratory performing minimally complex tests must file a separate certificate for each laboratory location

Exceptions:

  • Lab not in a fixed location, i.e. health screening fair or mobile van

  • Labs engaged in public health testing

  • Labs under a single hospital/commander may file a single (one certificate for all hospital’s waived testing sites) or multiple applications

Slide 27

CLIP – Laboratories performing Provider Performed Microscopy (PPM)

Definition of PPM

  • A test personally performed by one of the following practitioners:

    1. Physician

    2. Midlevel practitioner (nurse practitioner, midwife, physician assistant)

    3. Dentist

  • The procedure must be classified as moderately complex

  • The primary instrument is the microscope

  • The specimen is labile

  • Control materials are not available to monitor the entire testing process

  • Limited specimen handling or processing is required

Slide 28

CLIP – Laboratories performing Provider Performed Microscopy (PPM)

  • Laboratory qualifies for a certificate of PPM (not more than five sites per certificate) if it restricts its tests to Provider Performed Microscopy procedures and Waived tests.

  • PPM is a subcategory of Moderate complexity

  • Examples of tests: All direct mount preparations, KOH preparations, Fern tests, Urine sediment examinations

Slide 29

CLIP – laboratories performing tests of moderate and high complexity

Definition of high/moderate (Non-waived) complexity testing:

  • A test system, assay, and examination categorized as high/moderate complexity by the Federal Register (define by CMS and published by CDC)

Slide 30

CLIP – laboratories performing tests of moderate and high complexity

Requirements for a certificate of high/moderate complexity (at a minimum):

  • Must have a procedure manual

  • Must follow manufacturers instructions

  • Must run a control

  • Must enroll in proficiency testing (PT)

  • Must identify and resolve problems

  • Must be accredited

Slide 31

Application for a certificate of registration

  • Application must be made on form prescribed by OASD(HA) designee

  • Be signed by commander of the hospital or clinic

  • Describe characteristics of laboratory:

    • Test procedures and volume

    • Methodologies for each lab test

    • Qualifications of personnel

  • See Attachment (A) pages 1- 6

Slide 32

Application for a certificate of registration

  • Certificate is valid for two years.

  • Must obtain certificate before performing and reporting results

  • The laboratory must meet all CLIP standards

  • May undergo unannounced inspections by TSG or their designee

Slide 33

Minimal Complexity and PPM:

Must submit renewal application every 2 years

Must demonstrate compliance with CLIP:

testing and reporting is performed correctly

not performing tests not listed on application

correct specimen procurement and processing

Application for a certificate of registration

Slide 34

Application for certificate of registration

High and Moderate Complexity

  • Valid for two years

  • Must provide proof of accreditation:

    • within 11 months of issuance of registration

    • If proof of accreditation is not provided, suspension, revocation or limitations of laboratory registration testing will occur

Slide 35

CLIP CERTIFICATE REGISTRATION

  • PLEASE SEE ATTACHMENT (A) pages 1-6 (DoD Registration Form CLIP) for reference for the next slides presentation

  • PLEASE SEE ATTACHMENT (B) – Key to Registration Certificates

  • PLEASE SEE ATTACHMENT (C) – Instruction for Completing Registration Forms

Slide 36

CCLM website: www.afip.org/OCLAB

Slide 37

Page 1 – Cover page

Must accompany all applications or registration

Contains general information about the laboratory

When submitted, must be signed by director and organization commander

Each site must have its own cover sheet. You cannot combine different complexities under one cover sheet.

Slide 38

Page 2 – Minimal application

Application must have cover page and minimal complexity page

A certificate may have more than one site

Must enter lab information for each site

There is no limit to the number of minimal complexity sites that one director can direct

Slide 39

Page 3 – PPM application

Application must have cover page and PPM page

A certificate may have more than one site (5 max)

Must enter lab information for each site

Slide 40

Page 4 – Multiple sites (Mod/High complexity)

Used for a certificate with multiple sites

Must enter lab information for each site

Can direct no more than a combination of FIVE high/moderate complexity sites (includes PPM)

Slide 41

Page 5 – Moderate or High Complexity

Application must have cover page, page 5 and 6 (single site) or pages 4, 5, 6 (multiple sites)

This page addresses testing personnel information and educational qualifications

Applications must also be accompanied with a CV for the director

Slide 42

Page 6 – Moderate or High Complexity

This page addresses specialties, test volumes, and methods

Slide 43

Notification requirements

Laboratories must notify CLIP within 30 days of any changes in:

  • name

  • location

  • Director

  • New test – need PT order

    Notify accreditation program

  • Changes in “Activity Menu” -new tests, deletion of tests

  • Director change

Slide 44

Revocation of certificate

A certificate of registration may be revoked or suspended due to failure to:

  • Meet requirements of CLIP

  • Meet accreditation requirements

  • Meet proficiency testing requirements

  • Permit complaint inspections

  • Correct deficiencies

Slide 45

Certificate of registration

Questions?

Slide 46

Proficiency Testing (PT)

All high/moderate complexity laboratories must enroll in a proficiency testing program

Must enroll in an approved PT program for each specialty, subspecialties, analyte or test

Used for the primary method for patient testing

Slide 47

Proficiency Testing (PT)

Definition:

A method of establishing and maintaining the accuracy and reliability of its testing procedures.

Slide 48

Proficiency Testing (PT)

  • Required for all analytes listed in your Activity Menu

  • PT samples are sent from the approved PT provider (CAP) in each of three shipments (events) per year

  • Samples must be treated the same as regular patient samples (no special handling)

  • General acceptable score is 80% or better for each event except Blood Bank which is 100%

Slide 49

Proficiency Testing (PT) Do’s

  • Enrollment

  • Participation

  • Evaluation of results

  • Investigation of failures

  • Corrective actions

  • Maintenance of record

Slide 50

Proficiency Testing (PT) Don’ts

  • Test sample differently than patient specimens

  • Have same Tech (or Supervisor) always do the testing

  • Refer samples to another lab/Accept referred PT samples: Result in accreditation revocation, suspension and/or monetary fine

  • Discuss results before reporting

Slide 51

Proficiency Testing (PT) – successful participation

  • There is no distinction between regulated and non-regulated analytes

  • Most specialties must maintain at least a grade of 80% (micro, immuno, chem, hem, etc)

  • Pathologists/cytotechnologists must be individually tested every year (PAP PT)

  • Immunohematology (Blood Bank) must maintain a grade of 100%

Slide 52

PT Failures:Directed Plan of Corrective Action

  • CLIP Action 1 (CMS Scorecard 2)

    • First unsatisfactory PT performance

  • CLIP Action 2 (CMS Scorecard 3)

    • Unsuccessful performance in 2 of 3 testing events

  • CLIP Action 3

    • Repetitive (unsuccessful) PT failures. 3 out 4 testing events.

  • See Attachment D – Directed POA for Failed PT

Slide 53

Unsatisfactory PT:Directed Plan of Corrective Action

  • CLIP Action 1 (CMS Scorecard Risk Code 2)

  • First unsatisfactory PT performance

    • Perform investigation and correct problem

    • Verify corrective action

    • Document and retain for 2 years

Slide 54

Unsuccessful PT:Directed Plan of Corrective Action

  • CLIP Action 2 (CMS Scorecard at Risk Code 3)

  • Unsuccessful performance in 2 of 3 testing events

    • Will automatically generate a memo from CCLM to the lab director via the lab MTF CO

    • Discontinue testing until The ff actions are taken:

      • Perform investigation and correct problem

      • Verify corrective action by other than internal QC

    • Director approves resumption of testing

    • Document and retain for 2 years

    • Provide CCLM via fax or email attachment with documentation 72 hours after resumption of testing.

Slide 55

Repetitive PT failures:Directed Plan of Corrective Action

  • CLIP Action 3 - Repetitive PT Failures (3 out of 4 consecutive surveys)

    • Will automatically generate a memo from CCLM to the lab director via the lab MTF Commanding Officer

    • Discontinue testing of analyte or test

    • Follow CLIP Action 2 actions

    • CCLM will advise on actions to take prior to resumption of testing when all PCA and documentation where received and reviewed if there’s no “cease testing” order from CAP. Otherwise CAP will determine when they can start testing with CCLM concurrence.

Slide 56

Investigating PT Failures and Corrective Action

  • See Attachment D – Directed POA for Failed PT

  • See Attachment E – Reading Your PT Evaluation Report

  • See Attachment F – Investigation Flowchart

  • See Attachment G – PT Deviation Report from CAP

Slide 57

Closing PT Failures

  • Includes

    - Explanation of investigation

    - Documentation of external validation (reinstatement PT-paid by CCLM)

    - Impact on patient care

    - Implementation of new processes/procedures to prevent recurrence

    - Documentation send to CCLM and CAP

Slide 58

Not Closing PT Failures

  • Generates multiple memo from CCLM to MTF Commanding Officer via Laboratory Director until PT is resolved.

  • May results in sanctions:

    • Suspension or Cessation of testing

    • Suspension or revocation of accreditation

    • Suspension or revocation of CLIP certificate

Slide 59

Proficiency Testing

Questions?

Slide 60

Accreditation Inspections

  • Conducted biennially

  • Most labs use CAP, JCAHO or COLA

  • Purpose is to improve the quality of clinical laboratory services through voluntary participation, professional peer review, education, and compliance with established performance standards

Slide 61

ACCREDITATION INSPECTIONS

  • Most paperwork is handled directly with CAP ie. applications, medical director changes, etc

  • CCLM manages the centralized contract for CAP inspections – means CCLM pays

  • Automatically receive a final copy of all inspection report and automatically renew CLIP certificates

Slide 62

ACCREDITATION INSPECTIONS

  • Need to know

    • Unannounced inspection but CCLM know

      • Exceptions:

        • International (OCONUS)

        • Initial inspection

        • Reproductive and Forensic Drug Testing

    • CAP will send LAP package 6-9 months prior to anniversary date

      • Lab will complete application and send back to CAP

      • Recommend to add all your facility’s CLIP number including Waive and PPM ( Navy – required)

Slide 63

ACCREDITATION INSPECTIONS

  • Need to know

    • Out of cycle (non-routine) inspection may be funded by CCLM - (AF – no way)

    • Initial (New Lab) LAP application – must notify CCLM to add lab to the CAP contract. You don’t , you pay.

    • May request additional blackout date due to unexpected operational commitment

      • Must be coordinated through CCLM

Slide 64

Accreditation Inspections

Questions?

Thank you for coming and listening

NOW, lets go and discover N.O.

Slide 65

References

  • Public Law 100-578, CLIA-88

  • CMS/DOD MOA dated 16 Jan 2003

  • DODI 6440.2, 20 April 1994, establishes CLIP

  • AFIP Pamphlet 40-24 dated 1 November 2002 (DOD CLIP provides current guidance)

Slide 66

Useful websites

  • http://www.afip.org/OCLAB/index.html

  • www.phppo.cdc.gov/clia/testcat.aspx

  • www.cms.hhs.gov/clia/

  • www.cap.org/apps/cap.portal

  • www.jcaho.org

Slide 67

DoD-CLIP, CCLMPoints of Contact

Slide 68

General CCLM Office Information

  • ARMED FORCES INSTITUTE OF PATHOLOGY

    Office of Clinical Laboratory Affairs

    Center for Clinical Laboratory Medicine

    Bldg 54, Room G134

    6825 16TH Street NW, Washington, DC 20306

  • Homepage: http://www.afip.org/OCLAB/index.html

  • FAX: (202) 782-6022 DSN: 662-6022

Slide 69

ANY QUESTIONS OR COMMENTS

Thank you


Copyright © 2014 SlideServe. All rights reserved | Powered By DigitalOfficePro